Ebixa 5 mg film-coated tablets
Ebixa 10 mg film-coated tablets
Ebixa 15 mg film-coated tablets
Ebixa 20 mg film-coated tablets
Memantine hydrochloride
Read all of this leaflet carefully before you start taking this medicine
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet
1. What Ebixa is and what it is used for
2. Before you take Ebixa
3. How to take Ebixa
4. Possible side effects
5. How to store Ebixa
6. Further information
What Ebixa Is And What It Is Used For
How does Ebixa work
Ebixa belongs to a group of medicines known as anti-dementia medicines.
Memory loss in Alzheimer’s disease is due to a disturbance of message signals in the brain. The brain contains so-called N-methyl-D-aspartate (NMDA)-receptors that are involved in transmitting nerve signals important in learning and memory. Ebixa belongs to a group of medicines called NMDA-receptor antagonists. Ebixa acts on these NMDA-receptors improving the transmission of nerve signals and the memory.
What is Ebixa used for
Ebixa is used for the treatment of patients with moderate to severe Alzheimer’s disease.
Before You Take Ebixa
Do not take Ebixa
- if you are allergic (hypersensitive) to memantine hydrochloride or any of the other ingredients of Ebixa film-coated tablets (see section 6).
Take special care with Ebixa
- if you have a history of epileptic seizures
- if you have recently experienced a myocardial infarction (heart attack), or if you are suffering from congestive heart failure or from an uncontrolled hypertension (high blood pressure).
In these situations the treatment should be carefully supervised, and the clinical benefit of Ebixa reassessed by your doctor on a regular basis.
If you suffer from renal impairment (kidney problems), your doctor should closely monitor your kidney function and if necessary adapt the memantine doses accordingly.
The use of medicinal products called amantadine (for the treatment of Parkinson´s disease), ketamine (a substance generally used as an anaesthetic), dextromethorphan (generally used to treat cough) and other NMDA-antagonists at the same time should be avoided.
Ebixa is not recommended for children and adolescents under the age of 18 years.
Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
In particular, Ebixa may change the effects of the following medicines and their dose may need to be adjusted by your doctor:
amantadine, ketamine, dextromethorphan
dantrolene, baclofen
cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine
hydrochlorothiazide (or any combination with hydrochlorothiazide)
anticholinergics (substances generally used to treat movement disorders or intestinal cramps)
anticonvulsants (substances used to prevent and relieve seizures)
barbiturates (substances generally used to induce sleep)
dopaminergic agonists (substances such as L-dopa, bromocriptine)
neuroleptics (substances used in the treatment of mental disorders)
oral anticoagulants
If you go into hospital, let your doctor know that you are taking Ebixa.
Taking Ebixa with food and drink
You should inform your doctor if you have recently changed or intend to change your diet substantially (e.g. from normal diet to strict vegetarian diet) or if you are suffering from states of renal tubulary acidosis (RTA, an excess of acid-forming substances in the blood due to renal dysfunction (poor kidney function)) or severe infections of the urinary tract (structure that carries urine), as your doctor may need to adjust the dose of your medicine.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Tell your doctor if you are pregnant or planning to become pregnant. The use of memantine in pregnant women is not recommended.
Women taking Ebixa should not breast-feed.
Driving and using machines
Your doctor will tell you whether your illness allows you to drive and to use machines safely.
Also, Ebixa may change your reactivity, making driving or operating machinery inappropriate.
Important information about some of the ingredients of Ebixa
Ebixa 10 mg film-coated tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. Your doctor will advise you.
How To Take Ebixa
The Ebixa treatment initiation pack is only to be used for the beginning of the treatment with Ebixa.
Always take Ebixa exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Dosage
The recommended treatment dose of 20 mg per day is achieved by a gradual increase of the Ebixa dose during the first 3 weeks of treatment. The treatment scheme is also indicated on the treatment initiation pack. Take one tablet once a day.
Week 1 (day 1-7):
Take one 5 mg tablet once a day (white to off-white, oval-oblong) for 7 days.
Week 2 (day 8-14):
Take one 10 mg tablet once a day (white to off-white, centrally tapered oblong, biconvex, with a single breakline on both sides) for 7 days.
Week 3 (day 15-21):
Take one 15 mg tablet once a day (grey-orange, oval-oblong film) for 7 days.
Week 4 (day 22-28):
Take one 20 mg tablet per day (grey-red, oval-oblong film) for 7 days.
Maintenance dose
The recommended daily dose is 20 mg once a day.
For continuation of the treatment please consult your doctor.
Dosage in patients with impaired kidney function
If you have impaired kidney function, your doctor will decide upon a dose that suits your condition. In this case, monitoring of your kidney function should be performed by your doctor at specified intervals.
Administration
Ebixa should be administered orally once a day. To benefit from your medicine you should take it regularly every day at the same time of the day. The tablets should be swallowed with some water. The tablets can be taken with or without food.
Duration of treatment
Continue to take Ebixa as long as it is of benefit to you. Your doctor should assess your treatment on a regular basis.
If you take more Ebixa than you should
- In general, taking too much Ebixa should not result in any harm to you. You may experience increased symptoms as described in section 4. “Possible side effects”.
- If you take a large overdose of Ebixa, contact your doctor or get medical advice, as you may need medical attention.
If you forget to take Ebixa
- If you find you have forgotten to take your dose of Ebixa, wait and take your next dose at the usual time.
- Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible Side Effects
Like all medicines, Ebixa can cause side effects, although not everybody gets them.
In general, the observed side effects are mild to moderate.
Common (affects 1 to 10 users in 100):
- Headache, sleepiness, constipation, dizziness, shortness of breath, high blood pressure and drug hypersensitivity.
Uncommon (affects 1 to 10 users in 1,000):
- Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure and venous blood clotting (thrombosis/thromboembolism)
Very Rare (affects less than 1 user in 10,000):
- Seizures
Not known (frequency cannot be estimated from the available data):
- Inflammation of the pancreas and psychotic reactions
Alzheimer's disease has been associated with depression, suicidal ideation and suicide. These events have been reported in patients treated with Ebixa.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How To Store Ebixa
Keep out of the reach and sight of children.
Do not use Ebixa after the expiry date which is stated on the carton and the blister after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Further Information
What Ebixa contains
The active substance is memantine hydrochloride. Each tablet contains 5/10/15/20 mg of memantine hydrochloride equivalent to 4.15/8.31/12.46/16.62 mg memantine.
The other ingredients for Ebixa 5/15 and 20 mg film-coated tablets are microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, all in the tablet core; and hypromellose, macrogol 400, titanium dioxide (E 171) and additional for Ebixa 15 mg and Ebixa 20 mg film-coated tablets are iron oxide yellow and red (E 172), all in the tablet coating.
The other ingredients for Ebixa 10 mg film-coated tablets are lactose monohydrate, microcrystalline cellulose, colloidal anhydrous silica, talc and magnesium stearate, all in the tablet core; and methacrylic acid - ethyl acrylate copolymer (1:1), sodium lauryl sulphate, polysorbate 80, talc, triacetin and simethicone emulsion, all in the tablet coating.
What Ebixa looks like and contents of the pack
Ebixa 5 mg film-coated tablets are presented as white to off-white, oval-oblong with imprint ‘5’ on one side and imprint ‘MEM’ on the other side.
Ebixa 10 mg film-coated tablets are presented as white to off-white, centrally tapered oblong biconvex, film-coated tablets with a single breakline on both sides. The tablet can be divided into equal halves.
Ebixa 15 mg film-coated tablets are presented as orange to grey-orange, oval-oblong with imprint ‘15’ on one side and imprint ‘MEM’ on the other side. Ebixa 20 mg film-coated tablets are presented as are pale red to grey-red, oval-oblong with imprint ‘20’ on one side and imprint ‘MEM’ on the other side.
One treatment initiation pack contains 28 tablets in 4 blisters with 7 tablets of Ebixa 5 mg, 7 tablets of Ebixa 10 mg, 7 tablets of Ebixa 15 mg and 7 tablets of Ebixa 20 mg.
Marketing Authorisation Holder and Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
This leaflet was last approved in 06/2010
Detailed information on this product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu
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